Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Taipei Medical University
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT01765101
First received: January 4, 2013
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.


Condition Intervention Phase
Knee Osteoarthritis
Other: customized insoles
Other: ready made insoles
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Ready-made Full-length Lateral Wedged Insoles and Customized Full-length Lateral Wedged Insoles on Patients With Knee Osteoarthritis : a Double Blind, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Taipei Medical University:

Primary Outcome Measures:
  • pain [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    Visual analog scale, pain pressure threshold


Secondary Outcome Measures:
  • Physical functional ability [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time

  • psychological function [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire

  • functional performance [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score

  • quality of life [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life

  • balance performance [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk

  • physical activity [ Time Frame: change from baseline at one month and three months after modified shoe insoles wearing ] [ Designated as safety issue: No ]
    CHAMPS physical activity questionnaire


Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: customized insoles

customized full-length lateral wedged shoe insoles

1 month and 3 months study the immediate, short-term and intermediate-term therapeutic effects

Other: customized insoles
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
Other Name: customized full-length lateral wedged insoles: ICB
Placebo Comparator: ready made insoles

ready-made full-length lateral wedged shoe insoles at 1 and 3 months

study the immediate, short-term and intermediate-term therapeutic effects

Other: ready made insoles
To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
Other Name: ready made full-length lateral wedged insoles: La New

Detailed Description:

A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
  • with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment

Exclusion Criteria:

  • with a history of previous knee surgery with an implant
  • reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
  • pregnant or planning to become pregnant
  • self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765101

Contacts
Contact: Ru-Lan Hsieh, MD 886-2-28332211 ext 2531 M001052@ms.skh.org.tw

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Not yet recruiting
Taipei, Taiwan, 111-01
Contact: Ru-Lan Hsieh, MD    886-2-28332211 ext 2531    M001052@ms.skh.org.tw   
Principal Investigator: Ru-Lan Hsieh, MD         
Sponsors and Collaborators
Taipei Medical University
Investigators
Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
  More Information

No publications provided

Responsible Party: Ru-Lan Hsieh, MD, Associate professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01765101     History of Changes
Other Study ID Numbers: SKH-8302-102-DR-32
Study First Received: January 4, 2013
Last Updated: January 9, 2013
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Taipei Medical University:
knee osteoarthritis
therapeutic effect
insole

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 19, 2014